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PMA Final Decisions for June 2011

Thu, 08/18/2011 - 6:31am
U.S. Food & Drug Administration

Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions. This list is generated on a monthly basis.

A PDF document that contains the "Approval letter and Summary of Safety and Effectiveness" is being added to this listing for each PMA. The PMA number will appear as a link if this document is available.

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
P090002

6/13/11

Pinnacle® CoMplete® Acetabular Hip System DePuy Orthopaedics, Inc.

Warsaw, IN

46581

Approval for the Pinnacle® CoMplete® Acetabular Hip System. This device is indicated for:

The Pinnacle® CoMplete® Acetabular Hip System is a single use device intended for uncemented fixation. The Pinnacle® CoMplete® Acetabular Hip System is intended as a primary joint replacement prosthesis in total hip arthroplasty for skeletally mature patients suffering at least moderate pain in the hip joint from non-inflammatory degenerative joint

disease (NIDJD) and its composite diagnoses of osteoarthritis (OA) or post-traumatic

arthritis.

Pinnacle®" CoMplete® Acetabular Hip System's inserts (Pinnacle® Ultamet®) are only

intended for use with DePuy's femoral and acetabular components having matching outer

and inner diameters.

 

P100027

6/14/11

INFORM® HER2 Dual ISH DNA Probe Cocktail Ventana Medical Systems, Inc.

Tucson, AZ

85755

Approval for the INFORM® HER2 Dual ISH DNA Probe Cocktail. This device is indicated for:

The INFORM® HER2 Dual ISH DNA Probe Cocktail is intended for use in determining HER2 gene status by enumeration of the ratio of the HER2 gene to Chromosome 17. The HER2 and Chromosome 17 probes are detected using two color chromogenic in situ

hybridization (ISH) in formalin-fixed. paraffin-embedded human breast cancer tissue specimens following staining on Ventana BenchMark® XT automated slide stainers (using

NeXES software), by light microscopy. The I NFORM® H ER2 Dual ISH DNA Probe Cocktail is indicated as an aid in the assessment of patients for whom I-HERPCEPTIN

(trastuzumab) treatment is being considered.

This product should be interpreted by a qualified reader in conjunction with histological examination, relevant clinical information, and proper controls.

This reagent is intended for in vitro diagnostic (IVD) use.

P100031

6/22/11

Elecsys® Anti-HBc Immunoassay and Elecsys® PreciControl Anti-HBc for use on the MODULAR ANALYTICS E170 Immunoassay Analyzer Roche Diagnostics Corporation

Indianapolis, IN

46250

Approval for the Elecsys® Anti-HBc Immunoassay & Elecsys® PreciControl Anti-HBc for use on the MODULAR ANALYTICS E170 Immunoassay Analyzer. This device is indicated for the in vitro qualitative determination of total antibodies to hepatitis B core antigen (anti-HBc) in human serum and plasma (lithium-heparin, sodium-citrate, K 2 -EDTA) in adult patients with the symptoms of hepatitis or who may be at risk for hepatitis B (HBV) infection. The detection of total anti-HBc is indicative of a laboratory diagnosis for HBV infection. Further HBV serological marker testing is required to define the specific disease state. The Elecsys Anti-HBc immunoassay's performance has not been established for the monitoring HBV disease or therapy. The electro- chemiluminescence immunoassay "ECLIA" is intended for use on the MODULAR ANALYTICS EI70 Immunoassay Analyzer. The Elecsys Preci-Control Anti-HBc is used for quality control of the Elecsys Anti-HBc immunoassay on the MODULAR ANALYTICS E170

immunoassay analyzer.

P100032

6/27/11

Elecsys® Anti-HBc Immunoassay and

Elecsys® PreciControl Anti-HBc for use on the

Elecsys® 2010 Immunoassay Analyzer

Roche Diagnostics Corporation

Indianapolis, IN

46250

Approval for the Elecsys® Anti-HBc Immunoassay & Elecsys® PreciControl Anti-HBc for use on the Elecsys® 2010

Immunoassay Analyzer. This device is indicated for the in vitro qualitative determination of total antibodies to hepatitis B core antigen (anti-HBc) in human serum and plasma (lithium-heparin, sodium-citrate, K 2 -EDTA) in adult patients with the symptoms of hepatitis or who may be at risk for hepatitis B (HBV) infection. The detection of total anti-HBc is indicative of a laboratory diagnosis for HBV infection. Further HBV serological marker testing is required to define the specific disease state. The Elecsys Anti-HBc immunoassay's performance has not been established for the monitoring of HBV disease or therapy. The electrochemilumi-nescence immunoassay "ECLIA" is intended for use on the Elecsys 2010 Immunoassay Analyzer. The Elecsys PreciControl Anti-HBc is used for quality control of the Elecsys Anti-HBc immunoassay on the Elecsys 2010 immunoassay analyzer.

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
P820060/S027

6/10/11

180-Day

AxSYM AFP Abbott Laboratories Abbott Park, IL

60064

Approval for a manufacturing site located at Abbott Ireland Diagnostics Division in Sligo, Ireland.
P830061/S061

6/16/11

135-Day

CapSure, CapSure SP Novus, Vitatron Crystaline, Vitatron Excellence PS+ Leads Medtronic, Inc.

Mounds View, MN

55112

Approval for an alternate supplier for the sterile barrier trays and change in orientation of tooling ID number on the tray.
P830061/S062

6/27/11

135-Day

CapSure SP Novus Leads, CapSure, CapSure Sense Leads, Vitatron

Excellence PS+, Vitatron Crystalline

Medtronic, Inc.

Mounds View, MN

55112

Approval for the change of the cleaning control area and the associated processes.
P830063/S006

6/17/11

Real-Time

PRISMAFLEX TPE 2000 Set Gambro Renal Products

Lakewood, CO

80401

Approval for modifications to the Gambro Prisma TPE 2000 Set with Plasmafilter PF 2000N to permit the use of the plasmafilter with the Gambro PRISMAFLEX System. The device, as modified, will be marketed under the trade name PRISMAFLEX TPE 2000 Set and is indicated for therapeutic plasmapheresis.
P850089/S074

6/16/11

135-Day

CapSure Z Novus, CapSure SP Novus, Vitatron Excellence SS+, Vitatron Impulse II Leads Medtronic, Inc.

Mounds View, MN

55112

Approval for an alternate supplier for the sterile barrier trays and change in orientation of tooling ID number on the tray.
P850089/S075

6/27/11

135-Day

CapSure Z Novus Leads, CapSure SP Novus Leads, CapSure, Vitatron Excellence, Vitatron Excellence SS+, Vitatron Impluse II,

CapSure SP Z Leads

Medtronic, Inc.

Mounds View, MN

55112

Approval for the change of the cleaning control area and the associated processes.
P880047/S015

6/17/11

Real-Time

GYNECARE INTERCEED® Absorbable Adhesion Barrier Ethicon, Inc. Somerville, NJ

08876

Approval for a larger INTERCEED® product that measures 5”x6” in size. The device, as modified, is indicated as an adjuvant in open (laparotomy) gynecologic pelvic surgery for reducing the incidence of postoperative pelvic adhesions after meticulous hemostasis is achieved.
P880086/S204

6/8/11

Real-Time

Sustain XL Family of Pacemakers St. Jude Medical, Inc.

Sunnyvale, CA

94086

Approval for the new Sustain XL Pacemaker Models, predicated off

the Victory/Zephyr family of pacemaker. The device, as modified, will be marketed under the

trade name Sustain XL DR/SR and Sustain XL DC/SC and is indicated for

Indications and Usage

• Implantation of Sustain™ pulse generators is indicated in the following permanent conditions, when associated with symptoms including, but not limited to:

• Syncope

• Presyncope

• Fatigue

• Disorientation

• Or any combination of those symptoms.

Rate-Modulated Pacing is indicated for patients with chronotropic incompetence and for those who would benefit from increased stimulation rates concurrent with physical activity. Dual-Chamber Pacing (Models PM2134 and PM2136 only) is indicated for those patients exhibiting:

• Sick sinus syndrome

• Chronic, symptomatic second- and third-degree AV block

• Recurrent Adams-Stokes syndrome

• Symptomatic bilateral bundle branch block when tachyarrhythmia and other causes have been ruled out.

Atrial Pacing is indicated for patients with sinus node dysfunction and normal AV and

intraventricular conduction systems.

Ventricular Pacing is indicated for patients with significant bradycardia and:

• Normal sinus rhythm with only rare episodes of A-V block or sinus arrest

• Chronic atrial fibrillation

• Severe physical disability.

AF Suppression (Models PM2134 and PM2136 only) is indicated for suppression of paroxysmal or persistent atrial fibrillation episodes in patients with one or more of the above pacing indications.

P890003/S218

6/16/11

135-Day

CapSure VDD2, Brilliant S+ Leads Medtronic, Inc.

Mounds View, MN

55112

Approval for an alternate supplier for the sterile barrier trays and change in orientation of tooling ID number on the tray.
P890003/S219

6/27/11

135-Day

Prodigy lPG, Leads Wrench Kit, Leads Service Kit, Vitatron Brilliant S+, Capsure VDD Leads, Connector Port Pin-Plug Medtronic, Inc.

Mounds View, MN

55112

Approval for the change of the cleaning control area and the associated processes.
P890055/S034

6/21/11

Special

MedStream Programmable Infusion System Codman & Shurtleff, Incorporated

Raynham, MA

02767

Approval to add a warning statement to the Instructions for Use.
P900061/S100

6/27/11

135-Day

Ace Header, Patch Lead, Lead End Pin Cup Medtronic, Inc.

Mounds View, MN

55112

Approval for the change of the cleaning control area and the associated processes.`
P910007/S023

6/8/11

180-Day

ARCHITECT Total PSA Abbott Laboratories Abbott Park, IL

60064

Approval for manufacturing site located at Abbott Ireland Diagnostic Division in Sligo, Ireland.
P910007/S025

6/10/11

180-Day

AxSYM Total PSA Abbott Laboratories Abbott Park, IL

60064

Approval for a manufacturing site located at Abbott Ireland Diagnostics Division in Sligo, Ireland.
P910007/S026

6/22/11

180-Day

ARCHITECT Total PSA Abbott Laboratories

Abbott Park, IL

60064

Approval for a manufacturing site located at Abbott Ireland Diagnostics division in Sligo, Ireland.
P910023/S257

6/21/11

180-Day

Cadence/Current/ Fortify Family of ICDs St. Jude Medical

Sunnyvale, CA

94086

Approval for Software Model MN5000 V.5.0 for use on the Merlin.net System and Model EX2000 V.5.0 for use on Merlin@ home Devices.
P910023/S266

6/28/11

180-Day

Current Accel VR, DR ICDs and Fortify VR, DR ICDs St. Jude Medical

Sylmar, CA

91342

Approval for manufacturing site located at St. Jude Medical Puerto Rico LLC in Arecibo, Puerto Rico.
P910073/S089

6/14/11

135-Day

Reliance IS-1 Family of Leads Boston Scientific Corporation

St. Paul, MN

55112

Approval for acceptance of an enhancement to the insulation and tri-lumen bond process, to include an upgrade of the bonding equipment and additional acceptance activity inspections to verify an adequate bond which will prevent fluid leakage.
P910077/S115

6/21/11

Real-Time

LATITUDE Paceart Integration System Boston Scientific Corporation

St. Paul, MN

55112

Approval for modifications to the LATITUDE Paceart Integration (LPI) software, Model 6472 v1.01.
P920015/S074

6/27/11

135-Day

IS-l Port Pin Plug, Y Adaptor Kit, Lead Adaptor, Sprint Lead, Sprint

Quattro Lead, Sprint Quattro Secure Lead, Subcutaneous

Defibrillation Lead, Transvene SVC Lead, Tunneling Tool, Sub-Q

Lead, Sprint Quattro Single Coil

Medtronic, Inc.

Mounds View, MN

55112

Approval for the change of the cleaning control area and the associated processes.
P930039/S049

6/16/11

135-Day

CapSure Fix, CapSure Fix NovusSureFix Leads Medtronic, Inc.

Mounds View, MN

55112

Approval for an alternate supplier for the sterile barrier trays and change in orientation of tooling ID number on the tray.
P930039/S050

6/27/11

135-Day

CapSureFix Novus Lead, SureFix Novus Lead, CapSureFix Lead, Vitatron Pirouet Lead, Vitatron Crystalline Actfix Lead Medtronic, Inc.

Mounds View, MN

55112

Approval for the change of the cleaning control area and the associated processes.
P950024/S029

6/27/11

135-Day

CapSure EPI Unipolar Lead, CapSure EPI Bipolar Lead Medtronic, Inc.

Mounds View, MN

55112

Approval for the change of the cleaning control area and the associated processes.
P960007/S020

6/13/11

135-Day

TransCyte Human Fibroblast-Derived Temporary Skin Substitute Advanced BioHealing, Inc.

La Jolla, CA

92037

Approval for modification of the automated and manual cell expansion trypsinization processes for manufacturing TransCyte.
P960013/S065

6/28/11

180-day

Tendril STS Lead St. Jude Medical

Sylmar, CA

91342

Approval for manufacturing site located at St. Jude Medical Puerto Rico LLC in Arecibo, Puerto Rico.
P970004/S087

6/9/11

180-Day

Medtronic InterStim II Neurostimulator Medtronic, Inc.

Minneapolis, MN

55432

Approval for design and specification changes to the Model 3058 InterStim II battery.
P970004/S116

6/8/11

Special

Medtronic InterStim® Therapy for Urinary Control Medtronic, Inc.

Minneapolis, MN

55432

Approval for the addition of two precaution statements to the labeling of the Model 3037 patient programmer.
P970021/S030

6/13/11

135-Day

GYNECARE THERMACHOICE III Uterine Balloon Therapy System ETHICON, Inc. Somerville, NJ

08876

Approval for changes to the catheter balloon measurement process.
P970051/S069

6/3/11

Real-Time

Nucleus 24 Cochlear Implant System Cochlear Americas Centennial, CO 80111 Approval for a modified version of the external CP810 sound processor main BTE module (approved under P970051/S049), called Build Standard D, which is primarily intended to allow for repair of the processor.
P980007/S016

6/10/11

180-Day

AxSYM Free PSA Abbott Laboratories Abbott Park, IL

60064

Approval for a manufacturing site located at Abbott Ireland Diagnostics Division in Sligo, Ireland.
P980007/S017

6/22/11

180-Day

ARCHITECT Free PSA Abbott Laboratories

Abbott Park, IL

60064

Approval for a manufacturing site located at Abbott Ireland Diagnostics division in Sligo, Ireland.
P980016/S288

6/27/11

135-Day

Marquis ICD Family, Maximo ICD Family, Intrinsic ICD Family, CapSure Lead, EnTrust ICD Family, Virtuoso ICD Family, Maximo II lCD, Secura lCD, Virtuoso ICD Medtronic, Inc.

Mounds View, MN

55112

Approval for the change of the cleaning control area and the associated processes.
P980035/S211

6/27/11

135-Day

Sigma IPG Family, Medtronic 360 IPG Series, EnRhythm lPG, AT500 Systems, Adapta/ Versa/Sensia lPG, Relia IPG Medtronic, Inc.

Mounds View, MN

55112

Approval for the change of the cleaning control area and the associated processes.
P980035/S227

6/2/11

Real-Time

Adapta, Versa, Sensia and Relia Implantable Pulse Generators Medtronic, Inc.

Mounds View, MN

55112

Approval for an increase in gold thickness on XE263 accelerometer.
P980050/S059

6/27/11

135-Day

CS-SVC Transvene Lead Medtronic, Inc.

Mounds View, MN

55112

Approval for the change of the cleaning control area and the associated processes.
P990001/S086

6/27/11

135-Day

C-Series IPG, T-Series IPG Medtronic, Inc.

Mounds View, MN

55112

Approval for the change of the cleaning control area and the associated processes.
P990056/S011

6/20/11

135-Day

 

Elecsys total PSA Immunoassay Roche Diagnostics Corporation

Indianapolis, IN

46250

Approval for a change in the manufacturing site from buildings 341, 345 and 651 to building 761, all within the Roche Penzberg, Germany facility.
P000012/S027

6/27/11

135-Day

COBAS AMPLICOR HCV Test, COBAS Ampliprep/COBAS AMPLICOR HCV Test Roche Molecular Systems, Inc.

Pleasanton, CA

94588

Approval for changes to the test methods 1) magnetic susceptibility; and 2) surface area of the Tosylated magnetic beads used by the vendor.
P000027/S009

6/20/11

135-Day

Elecsys free PSA Immunoassay Roche Diagnostics Corporation

Indianapolis, IN

46250

Approval for a change in the manufacturing site from buildings 341, 345 and 651 to building 761, all within the Roche Penzberg, Germany facility.
P000053/S036

6/13/11

135-Day

AMS 800 Artificial Urinary Sphincter American Medical Systems, Inc.

Minnetonka, MN

55343

Approval for a new component mold.
P000053/S037

6/24/11

180-Day

AMS Sphincter 800® Urinary Prosthesis American Medical Systems, Inc.

Minnetonka, MN

55343

Approval for modifications to the design specifications and manufacturing process of the AMS 800 Control Pump, a component of the AMS Sphincter 800® Urinary Prosthesis.
P010015/S111

6/16/11

135-Day

Attain Lead Medtronic, Inc.

Mounds View, MN

55112

Approval for an alternate supplier for the sterile barrier trays and change in orientation of tooling ID number on the tray.
P010015/S112

6/27/11

135-Day

InSync III CRT-P, Attain OTW Lead, Attain Bipolar OTW Lead, Attain LV Lead Medtronic, Inc.

Mounds View, MN

55112

Approval for the change of the cleaning control area and the associated processes.
P010031/S242

6/27/11

135-Day

InSync II Marquis lCD, InSync III Marquis lCD, InSync Marquis

lCD, InSync Sentry ICD family, InSync Maximo ICD family,

Concerto CRT-D, Maximo II CRT-D, Consulta CRT-D, Concerto II

CRT-D

Medtronic, Inc.

Mounds View, MN

55112

Approval for the change of the cleaning control area and the associated processes.
P010050/S011

6/24/11

180-Day

IMMULITE® 2000 HBsAG Confirmatory Kit Siemens Healthcare Diagnostics

Norwood, MA

02062

Approval for an automated means of confirmation testing on-board the IMMULITE® 2000 immunoassay analyzer. The device, as modified, will be marketed under the trade name IMMULITE® 2000 HBsAg Confirmatory Kit and is indicated for:

IMMULITE 2000 HBsAg Confirmatory is intended for in vitro diagnostic use with

IMMULITE 2000 analyzers in conjunction with the IMMULITE 2000 HBsAg assay - for

the confirmation of the presence of hepatitis B surface antigen (HBsAg) in human serum or plasma (EDTA, heparinized, citrate) that were repeatedly reactive when tested by the IMMULITE/ IMMULITE 1000 HBsAg assay or by the IMMULITE 2000 HBsAg assay.

P020018/S037

6/7/11

180-Day

Zenith Flex® AAA Endovascular Graft Cook, Inc.

Bloomington, IN

47402

Approval to add the Zenith Spiral-Z® AAA Endovascular Graft Iliac Leg to the

existing Zenith Flex® AAA Endovascular Graft product line. The device, as modified, will be

marketed under the trade name Zenith Spiral-Z® AAA Endovascular Graft Iliac Leg and is

indicated for use with the Zenith AAA Endovascular Graft family of products, including the Zenith Flex AAA Endovascular Graft, Zenith Renu Ancillary Graft, Zenith Fenestrated AAA Endovascular Graft, or Zenith Branch Iliac Endovascular Graft, during either a primary or

secondary procedure in patients who have adequate iliac/femoral access compatible with the

required introduction systems. The graft is used in combination with these products for the endovascular treatment of abdominal aortic and aorto-iliac aneurysms.

P020047/S029

6/16/11

135-Day

Multi-Link Vision, Multi-Link Mini-Vision OTW and RX, Multi-Link 8, Multi-Link 8LL, Multi-Link 8 SV Coronary Stent Systems Abbott Vascular, Inc.

Temecula, CA

92590

Approval to remove a redundant receiving inspection test.
P030009/S054

6/9/11

Real-Time

Integrity Coronary Stent System Medtronic Vascular Santa Rosa, CA 95403 Approval for addition of labeling regarding simultaneous use of the Integrity RX stent system with either another Integrity RX stent system, or with a Sprinter Legend RX balloon dilation catheter. In addition, approval to revise the MRI compatibility information in the labeling.
P030035/S084

6/28/11

180-Day

Promote Accel

CRT-D

St. Jude Medical

Sylmar, CA

91342

Approval for manufacturing site located at St. Jude Medical Puerto Rico LLC in Arecibo, Puerto Rico.
P030036/S027

6/27/11

135-Day

SelectSecure Lead, Sleeve Kit Medtronic, Inc.

Mounds View, MN

55112

Approval for the change of the cleaning control area and the associated processes.
P030054/S181

6/21/11

180-Day

Epic HF/Atlas+HF/ Promote/Unify Family of CRT-Ds St. Jude Medical

Sunnyvale, CA

94086

Approval for Software Model MN5000 V.5.0 for use on the Merlin.net System and Model EX2000 V.5.0 for use on Merlin@ home Devices.
P030054/S191

6/28/11

180-Day

Quickflex µ Leads, Unify CRT-Ds St. Jude Medical

Sylmar, CA

91342

Approval for manufacturing site located at St. Jude Medical Puerto Rico LLC in Arecibo, Puerto Rico.
P040020/S029

6/30/11

180-Day

AcrySof IQ ReSTOR IOL Alcon Research, Ltd. Fort Worth, TX

76134

Approval for a manufacturing site located at Alcon Laboratories Ireland Ltd. in Cork, Ireland.
P040048/S014

6/2/11

Special

Trilogy AB® Acetabular System Zimmer, Inc.

Warsaw, IN

46581

Approval for adding information about MRI safety to the package insert and patient labeling.
P050011/S002

6/17/11

135-Day

ADEPT Adhesion Reduction Solution (4% Icodextrin) Baxter Healthcare Corporation

McGaw Park, IL

60085

Approval to implement the assay for detecting the amount of peptidoglycan (PG) in the Icodextrin Active Pharmaceutical Ingredient (API).
P050012/S037

6/3/11

Real-Time

DexCom Seven and Seven Plus Continuous Glucose Monitoring Systems DexCom, Inc.

San Diego, CA 92121

Approval for replacement of an obsolete LCD in the receiver assembly with a similar component and minor modifications to the receiver firmware to accommodate the new hardware.
P050028/S011

6/24/11

135-Day

COBAS AmpliPrep/ COBAS TaqMan HBV Test Roche Molecular Systems, Inc.

Pleasanton, CA

94588

Approval for an addition of a second sintering oven for the manufacture of the bulk Magnetic Glass Particle (MGP) raw material used in the production of the MPG reagent.
P050042/S012

6/1/11

180-Day

ARCHITECT Anti-HCV Abbott Laboratories

Irving, TX

75038

Approval for a manufacturing site located at Flextronics Manufacturing (S) Pte Ltd. in Singapore.
P050046/S009

6/29/11

135-Day

ACUITY™ Steerable Stylet Accessory Boston Scientific Corporation

St. Paul, MN

55112

Approval for acceptance of a change to relocate a sensor on wire grinding equipment and formalize inspections as acceptance activities.
P050051/S012

6/1/11

180-Day

ARCHITECT AUSAB Abbott Laboratories

Irving, TX

75038

Approval for a manufacturing site located at Flextronics Manufacturing (S) Pte Ltd. in Singapore.
P060003/S005

6/9/11

Real-Time

Abbott AxSYM AUSAB Abbott Laboratories

Abbott Park, IL

60064

Approval for changes to the manufacturing and quality control testing for AxSYM AUSAB Calibrators, Controls, and Reagents.
P060007/S014

6/1/11

180-Day

ARCHITECT HBsAg/

Confirmatory

Abbott Laboratories

Irving, TX

75038

Approval for a manufacturing site located at Flextronics Manufacturing (S) Pte Ltd. in Singapore.
P060033/S064

6/2/11

180-Day

Endeavor Sprint Zotarolimus-Eluting Coronary Stent Systems Medtronic Vascular

Santa Rosa, CA

95403

Approval for changes to the instructions for use (with the latest available follow-up clinical data from the Endeavor clinical trial programs).
P060035/S008

6/1/11

180-Day

ARCHITECT CORE-M Abbott Laboratories

Irving, TX

75038

Approval for a manufacturing site located at Flextronics Manufacturing (S) Pte Ltd. in Singapore.
P060039/S023

6/16/11

135-Day

Attain StarFix Lead Medtronic, Inc.

Mounds View, MN

55112

Approval for an alternate supplier for the sterile barrier trays and change in orientation of tooling ID number on the tray.
P060039/S024

6/27/11

135-Day

Attain StarFix Lead Medtronic, Inc.

Mounds View, MN

55112

Approval for the change of the cleaning control area and the associated processes.
P070015/S058

6/16/11

135-Day

XIENCE V and Promus Everolimus Eluting Coronary Stent Systems Abbott Vascular, Inc.

Temecula, CA

92590

Approval to remove a redundant receiving inspection test.
P070026/S001

6/7/11

180-Day

Ceramax Ceramic Total Hip System DePuy, Inc.

Warsaw, IN

46581

Approval of post-approval study protocol.
P080004/S007

6/15/11

Real-Time

iSert® Hoya Surgical Optics, Inc.

Chino Hills, CA

91709

Approval for packaging changes to the Model PY-60AD. The device, as modified, will be marketed under the trade name iSert® Model PY-60ADC and is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed.
P080006/S021

6/27/11

135-Day

Attain Ability Lead Medtronic, Inc.

Mounds View, MN

55112

Approval for the change of the cleaning control area and the associated processes.
P080023/S008

6/1/11

180-Day

ARCHITECT CORE Abbott Laboratories

Irving, TX

75038

Approval for a manufacturing site located at Flextronics Manufacturing (S) Pte Ltd. in Singapore.
P080025/S008

6/10/11

Special

Medtronic® InterStim® Therapy System Medtronic, Inc. Minneapolis, MN

55432

Approval for changes to the labeling for the 3037 Patient Programmer to add new precautions relating to modification of the device and the effect of electromagnetic interference (EMI) on the patient programmer’s ability to communicate with the neurostimulator.
P080032/S005

6/10/11

180-Day

Alair® Bronchial Thermoplasty System Asthmatx, Inc.

Sunnyvale, CA

94089

Approval for a manufacturing site located at Asthmatx, Inc. in Sunnyvale, California.
P080032/S007

6/21/11

180-Day

Alair® Bronchial Thermoplasty System Boston Scientific Corporation

Sunnyvale, CA

94089

Approval of the post approval study protocol.
P090013/S010

6/16/11

135-Day

CapSure Fix MRI Lead Medtronic, Inc.

Mounds View, MN

55112

Approval for an alternate supplier for the sterile barrier trays and change in orientation of tooling ID number on the tray.
P090013/S011

6/27/11

135-Day

Revo IPG, Revo MRI Lead Medtronic, Inc.

Mounds View, MN

55112

Approval for the change of the cleaning control area and the associated processes.
P100010/S010

6/28/11

Real-Time

Arctic Front® Cardiac Cryoablation Catheter Medtronic CryoCath, LP

Eagan, MN

55123

Approval for changes to the labeling to include compatibility for use with the Medtronic Achieve Mapping Catheter.
P100018/S001

6/27/11

180-Day

Pipeline Embolic Device Chestnut Medical Technologies, Inc.

Meno Park, CA

94025

Approval of post- approval study protocol.

30-Day Notices (135 Day Supplement was not required)

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
N18033/S056

6/10/11

VISTAKON (etafilcon A) and (senofilcon) Brand Contact Lenses Vision Care, Inc.

Jacksonville, FL

32256

Replacement of a Differential Scanning Calorimeter (DSC) for a previous model that is no longer supported by the same manufacturer.
N18033/S057

6/8/11

VISTAKON (etafilcon A) Brand Contact Lenses Johnson & Johnson Vision Care, Inc.

Jacksonville, FL

32256

Evaluation of the automation of the repackaging activities conducted by a qualified supplier.
N18033/S058

6/16/11

VISTAKON (etafilcon A) Brand Contact Lenses Johnson & Johnson Vision Care, Inc.

Jacksonville, FL

32256

Change in the software for processing laboratory data related to the VISTAKON® (etafilcon A) Brand and VISTAKON® (senofilcon A) Brand Contact Lenses.
N18033/S059

6/22/11

VISTAKON (etafilcon A) Brand Contact Lenses Johnson & Johnson Vision Care, Inc.

Jacksonville, FL

32256

Use an electronic Raw Material Tracking System.
P820003/S106

6/10/11

Disposable Cover Medtronic, Inc. Mounds View, MN

55112

Change the cleaning area of the devices.
P820021/S033

6/8/11

Vifilcon A Soft Contact Lenses for Extended Wear CIBA VISION Corporation

Duluth, GA

30097

Change the Alternate Raw Material Sourcing for (Vifilcon A formulation) Soft Contact Lens Materials.
P830060/S069

6/17/11

Tachy Adapter Boston Scientific Corporation

St. Paul, MN

55112

Alternate ingredient for the adhesive used in sterile packaging.
P830061/S065

6/10/11

CapSure and Vitatron Excellence+ Medtronic, Inc. Mounds View, MN

55112

Change the cleaning area of the devices.
P840001/S186

6/16/11

Restore Family of Implantable Neurostimulators, Itrel 3 Implantable Neurostimulator,

Synergy Family of Implantable Neurostimulators,

Specify Surgical Leads,

Hinged 2X4 Surgical Leads,

Resume Surgical Leads,

SymMix Surgical Leads,

1X8 Lead Family, Pisces Lead Family, Quadripolar Extensions, 1X8 Extensions,

1X8 Synergy Extensions,

Low Profile Quadripolar, Extensions, Accessories and Accessory Kits for use with Spinal Cord Stimulation Devices, Adaptors and

Control Magnet

Medtronic, Inc.

Minneapolis, MN

55432

Implement or change software used for manufacturing of several devices.
P840001/S187

6/17/11

7425 Itrel 3 IPG, 7427 Synergy IPG, 7427V Synergy Versitrel IPG, 37701

RestorePrime INS, 37702 PrimeAdvanced INS, 37711 Restore INS, 37712 RestoreUltra INS, and 37713 RestoreAdvanced INS

Medtronic Neuromodulation

Minneapolis, MN

55432

Addition of an ethylene oxide sterilizer system.
P840001/S188

6/22/11

Intrel 3, Synergy Family Medtronic Neuromodulation

Minneapolis, MN

55432

Addition of an alternate qualified supplier for components used in the feedthrough assembly.
P850089/S077

6/10/11

CapSure SP Z Leads, Vitatron Impulse, Vitatron Excellence S+, Vitratron Excellence SS+ and Vitatron Impulse II Medtronic, Inc. Mounds View, MN

55112

Change the cleaning area of the devices.
P860004/S152

6/16/11

Synchromed II Implantable Infusion Pumps, Intra-arterial Vascular Catheters, InDura IP Intrathecal Catheters, Intrathecal Catheters, Refill Kits, Sutureless Pump Connector Revision Kits,

Proximal Catheter Revision Kits, Distal Catheter Revision Kits, Accessories and Accessory Kits for use with Programmable Infusion

Pumps, Intraspinal Trial Kits and Programmer Power Adaptor

Medtronic, Inc.

Minneapolis, MN

55432

Implement or change software used for manufacturing of several devices.
P860022/S058

6/22/11

Boston Equalens/Equalens II Bausch & Lomb Incorporated

Rochester, NY

14609

Alternate supplier of 0.2 micron formulation filter.
P880047/S016

6/30/11

GYNECARE INTERCEED Absorbable Adhesion Barrier Ethicon, Inc.

Somerville, NJ

08876

Alternative cycle parameters for the manufacturing process.
P890003/S223

6/8/11

Prodigy IPG Medtronic, Inc.

Mounds View, MN

55112

Changes to the NeliPak Sealer manufacturing process; including addition of new equipment, a change to the process recipe specification, and the implementation of a monitoring test.
P890003/S224

6/9/11

Prodigy IPG Medtronic, Inc.

Mounds View, MN

55112

Addition of an ethylene oxide (EtO) sterilizer system.
P890003/S225

6/10/11

CapSure (Drug Eluting), ECG Cable Medtronic, Inc. Mounds View, MN

55112

Change the cleaning area of the devices.
P900060/S042

6/30/11

Carbomedics Prosthetic Heart Valve (CPHV), Carbo-Seal Ascending Aortic Prosthesis (AAP), Carbo-Seal Valsalva Ascending Aortic Prosthesis, Orbits Prosthetic Heart Valve, OptiFoam Prosthetic Mitral Heart Valve Sorin Group USA, Inc.

Arvada, CO

80004

Change of a supplier for lock wire components.
P900060/S043

6/30/11

Carbomedics Prosthetic Heart Valve (CPHV), Carbo-Seal Ascending Aortic Prosthesis (AAP), Carbo-Seal Valsalva Ascending Aortic Prosthesis, Orbits Prosthetic Heart Valve, OptiFoam Prosthetic Mitral Heart Valve Sorin Group USA, Inc.

Arvada, CO

80004

Analytical services supplier change.
P900060/S044

6/30/11

Carbomedics Prosthetic Heart Valve (CPHV), Carbo-Seal Ascending Aortic Prosthesis (AAP), Carbo-Seal Valsalva Ascending Aortic Prosthesis, Orbits Prosthetic Heart Valve, OptiFoam Prosthetic Mitral Heart Valve Sorin Group USA, Inc.

Arvada, CO

80004

Addition of a new Optical OGP SmartScope System to an existing component inspection.
P900061/S103

6/10/11

Upsizing Sleeve for HV Lead DF-1, Upsizing Sleeve, Epicardial Patch Leads Medtronic, Inc. Mounds View, MN

55112

Change the cleaning area of the devices.
P910001/S048

6/8/11

ELCA Coronary Artherectomy Catheters Spectranetics Corporation

Colorado Springs, CO

80921

Addition of an alternate supplier for a device component.
P910007/S030

6/24/11

ARCHITECT Total PSA Abbott Laboratories

Abbott Park, IL

60064

Change in the quality control testing used on an incoming raw material and a finished accessory used in ARCHITECT Total PSA and ARCHITECT Free PSA Assays.
P910073/S097

6/2/11

Endotak Reliance EZ, Endotak Reliance RX, Endotak Reliance

4-site EZ and Endotak Reliance 4-site RX Leads

Boston Scientific Corporation

St. Paul, MN

55112

Reduction in sample size.
P910073/S098

6/17/11

ENDOTAK Lead, ENDOTAK RELIANCE Lead, ENDOTAK Endurance Lead Brady Adapter, and Tachy Adapter Boston Scientific Corporation

St. Paul, MN

55112

Alternate ingredient for the adhesive used in sterile packaging.
P910077/S116

6/17/11

ENDOTAK Lead, Tachy Adapter Boston Scientific Corporation

St. Paul, MN

55112

Alternate ingredient for the adhesive used in sterile packaging.
P920015/S077

6/10/11

Transvene SVC Lead Medtronic, Inc. Mounds View, MN

55112

Change the cleaning area of the devices.
P930029/S030

6/10/11

RF Marinr, RF Marinr NTC, 5F RF Marinr, RF Conductr, RF Enhancr II, RF Conactr Medtronic, Inc. Mounds View, MN

55112

Change the cleaning area of the devices.
P930039/S053

6/10/11

Vitatron Pirouet/S+, Vitatron Crystalline ActFix, CapSure Medtronic, Inc. Mounds View, MN

55112

Change the cleaning area of the devices.
P930039/S055

6/29/11

CapSureFix and Crystalline Act Fix Medtronic, Inc.

Mounds View, MN

55112

A lead assembly crimping process improvement.
P950020/S044

6/30/11

Flextome® Cutting Balloon® Dilation Device Boston Scientific Corporation

Maple Grove, MN

55311

Implementation of the use of a closed-loop control (feedback), in the extrusion of the tie layer of the tri-layer component.
P960006/S031

6/17/11

FLEXTEND Lead Boston Scientific Corporation

St. Paul, MN

55112

Alternate ingredient for the adhesive used in sterile packaging.
P960009/S116

6/16/11

Activa Family of Implantable Neurostimulators, Soletra Implantable Neurostimulator,

Kinetra Implantable Neurostimulator, Leads,

Stereotactic Frame Lead Kit

Extensions, Adaptors, Accessory Kits used with Deep Brain Stimulation, Control Magnet

Medtronic, Inc.

Minneapolis, MN

55432

Implement or change software used for manufacturing of several devices.
P960009/S117

6/17/11

7426 Soletra INS, 7428 Kinetra INS, 37601 Activa PC INS, 37602 Activa

SC INS, 37603 Activa SC INS, and 37612 Activa RC INS

Medtronic Neuromodulation

Minneapolis, MN

55432

Addition of an ethylene oxide sterilizer system.
P960009/S118

6/22/11

Activa SC, Soletra, Kinetra Medtronic Neuromodulation

Minneapolis, MN

55432

Addition of an alternate qualified supplier for components used in the feedthrough assembly.
P960040/S244

6/17/11

CONFIENT PG, VENTAK PRIZM PG, VITALITY PG, TELIGEN PG Boston Scientific Corporation

St. Paul, MN

55112

Alternate ingredient for the adhesive used in sterile packaging.
P960042/S030

6/8/11

SLS Spectranetics Laser Sheaths Spectranetics Corporation

Colorado Springs, CO

80921

Addition of an alternate supplier for a device component.
P970003/S127

6/3/11

VNS Therapy System Pulse Generator Cyberonics

Houston, TX

77058

Make changes to software used in an electrical testing system.
D970003/S129

6/17/11

INSIGNIA PG, ALTRUA PG Boston Scientific Corporation

St. Paul, MN

55112

Alternate ingredient for the adhesive used in sterile packaging.
P970004/S113

6/16/11

Interstim Family of Implantable Neurostimulators

Leads, Extension, Test Stimulation Lead, Test Stimulation Kit, Accessories and Accessory Kits for use with Interstim therapy and

Control Magnet

Medtronic, Inc.

Minneapolis, MN

55432

Implement or change software used for manufacturing of several devices.
P970004/S114

6/17/11

3023 InterStim INS and 3058 InterStim II INS Medtronic Neuromodulation

Minneapolis, MN

55432

Addition of an ethylene oxide sterilizer system.
P970004/S115

6/22/11

InterStim Family Medtronic Neuromodulation

Minneapolis, MN

55432

Addition of an alternate qualified supplier for components used in the feedthrough assembly.
P970012/S085

6/10/11

Kappa 400 IPG Medtronic, Inc. Mounds View, MN

55112

Change the cleaning area of the devices.
P970027/S014

6/22/11

AxSYM Anti-HCV Abbott Laboratories

Abbott Park, IL

60064

Modification to a supplier of the antifoam solution used in AxSYM Anti-HCV.
P970037/S006

6/24/11

AutoDELFIA/DELFIA Xpress hAFP Test System PerkinElmer, Inc. Waltham, MA 02451 Change in the TOPO (Trioctylphosphine oxide) raw material type used in the manufacturing of the DELFIA Inducer.
P970051/S071

6/15/11

Nucleus 24 Cochlear Implant System Cochlear Americas

Centennial, CO

80111

Change from a manual assembly to an automated assembly of the case of the sound processor battery pack.
P970051/S076

6/15/11

 

Nucleus 24 Cochlear Implant System Cochlear Americas

Centennial, CO

80111

Extension of the cure time in the moulding process.
P970051/S077

6/15/11

Nucleus 24 Cochlear Implant System Cochlear Americas

Centennial, CO

80111

Changes to the production of the solid ball assembly electrode.
P980006/S019

6/10/11

Bausch & Lomb PureVision (balafilcon A) Soft Contact Lenses Bausch & Lomb, Incorporated

Rochester, NY

14609

Upgrade the Cognex software for the automated Wet Vision Automated Inspection System (AIS) to Version 4.4.
P980007/S021

6/24/11

ARCHITECT Free PSA Abbott Laboratories

Abbott Park, IL

60064

Change in the quality control testing used on an incoming raw material and a finished accessory used in ARCHITECT Total PSA and ARCHITECT Free PSA Assays.
P980016/S300

6/8/11

Secura DR/VR t Virtuoso II DR /VR, Maximo II DR/VR t EnTrust,

Virtuoso, Maximo, Intrinsic, Protecta, and Protecta XT Families of

ICDs

Medtronic, Inc.

Mounds View, MN

55112

Changes to the NeliPak Sealer manufacturing process; including addition of new equipment, a change to the process recipe specification, and the implementation of a monitoring test.
P980016/S301

6/9/11

Entrust, Intrinsic, Marquis, Maximo, Maximo II, Maximo II M4, Protecta XT/ Protecta, Protecta XT M4, Protecta M4, Secura, Secura M4, Virtuoso, Virtuoso II ICDs Medtronic, Inc.

Mounds View, MN

55112

Addition of an ethylene oxide (EtO) sterilizer system.
P980016/S302

6/10/11

Protecta DR, Protecta VR, Protecta XT DR and Protecta XT VR ICDs Medtronic, Inc. Mounds View, MN

55112

Change the cleaning area of the devices.
P980035/S224

6/8/11

Adpta/Versa/Sensia, Sigma, Relia, Advisa DR, EnRythm Families of

IPGs

Medtronic, Inc.

Mounds View, MN

55112

Changes to the NeliPak Sealer manufacturing process; including addition of new equipment, a change to the process recipe specification, and the implementation of a monitoring test.
P980035/S225

6/9/11

Adapta, Advisa, EnRhythm, Relia, Sensia, Versa IPGs Medtronic, Inc.

Mounds View, MN

55112

Addition of an ethylene oxide (EtO) sterilizer system.
P980035/S226

6/10/11

Advisa DR IPG Medtronic, Inc. Mounds View, MN

55112

Change the cleaning area of the devices.
P980035/S229

6/22/11

Advisa IPG Medtronic, Inc. Mounds View, MN

55112

Changes to testing software.
P980037/S037

6/8/11

AngioJet Rheolytic Thrombectomy System Medrad, Inc.

Minneapolis, MN

55433

Modification of a wiping procedure.
P990034/S022

6/16/11

Side Catheter Access Port Kits

Side Catheter Access Port Kits, bulk, Refill Kits

Refill Kits, bulk

Medtronic, Inc.

Minneapolis, MN

55432

Implement or change software used for manufacturing of several devices.
P010012/S267

6/17/11

EASYTRAK Lead, ACUITY Lead, CONTAK RENEWAL PG, LIVIAN ICD, COGNIS, Left Ventricular Lead Adapter Boston Scientific Corporation

St. Paul, MN

55112

Alternate ingredient for the adhesive used in sterile packaging.
P010013/S036

6/29/11

NovaSure Impedance Controlled Endometrial Hologic, Inc.

Marlborough, MA

01752

Change in manufacturing materials.
P010015/S122

6/8/11

Syncra and Consulta CRT-Ps Medtronic, Inc.

Mounds View, MN

55112

Changes to the NeliPak Sealer manufacturing process; including addition of new equipment, a change to the process recipe specification, and the implementation of a monitoring test.
P010015/S123

6/9/11

Consulta/Syncra CRT-PS Medtronic, Inc.

Mounds View, MN

55112

Addition of an ethylene oxide (EtO) sterilizer system.
P010015/S124

6/10/11

Syncra and Consulta CRT-P Medtronic, Inc. Mounds View, MN

55112

Change the cleaning area of the devices.
P010015/S127

6/22/11

Consulta CRT-P, Syncra

CRT-P

Medtronic, Inc. Mounds View, MN

55112

Changes to testing software.
P010031/S254

6/8/11

Consulta, Concerto II, Maximo II and InSync II Protect Families of

CRT-Ds; Concerto, InSync II, Marquis DR, InSync III Marquis,

InSync Marquis, InSync Maximo, and InSync Sentry Families of ICDs

Medtronic, Inc.

Mounds View, MN

55112

Changes to the NeliPak Sealer manufacturing process; including addition of new equipment, a change to the process recipe specification, and the implementation of a monitoring test.
P010031/S255

6/9/11

Concerto, Concerto II, Consulta, Consulta DF4, InSync II Marquis, InSync Marquis, InSync Maximo, InSync Sentry, Maximo II, Maximo II M4, Protecta XT/ Protecta CRT-D, Protecta XT M4/ Protecta M$ CRT-Ds Medtronic, Inc.

Mounds View, MN

55112

Addition of an ethylene oxide (EtO) sterilizer system.
P010031/S256

6/10/11

Protecta and Protecta XT CRT-D Medtronic, Inc. Mounds View, MN

55112

Change the cleaning area of the devices.
P010062/S009

6/22/11

Boston Orthokeratology Shapring Lens for Overnight Wear Bausch & Lomb Incorporated

Rochester, NY

14609

Alternate supplier of 0.2 micron formulation filter.
P020004/S063

6/8/11

Gore Excluder AAA Endoprosthesis W.L. Gore & Associates Inc.

Flagstaff, AR

86003

Automation of a bonding process.
P020009/S074

6/30/11

Express 2® Coronary Stent System Boston Scientific Corporation

Maple Grove, MN

55311

Implementation of the use of a closed-loop control (feedback), in the extrusion of the tie layer of the tri-layer component.
P030005/S076

6/2/11

Contak Renewal Models Boston Scientific Corporation

St. Paul, MN

55112

Various changes in hybrid level test.
P030005/S077

6/17/11

CONTAK RENEWAL TR PG Boston Scientific Corporation

St. Paul, MN

55112

Alternate ingredient for the adhesive used in sterile packaging.
P030017/S120

6/16/11

Precision Spinal Cord Stimulator System, Implantable Pulse Generator Charge Coil Boston Scientific Neuromodulation Valencia, CA

91355

Addition of an alternate qualified supplier for components used in assembly of the device.
P030026/S023

6/14/11

 

VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator Ortho-Clinical Diagnostic, Inc.

Rochester, NY

14626

Manufacturing process change for the manufacture and storage of the antifoam solution used in the VITROS Anti-HBc IgM Conjugate Reagent.
P030050/S010

6/14/11

Sculptra and Sculptra Aesthetic (infectable poly-L- lactic acid) Sanofi-Aventis U.S., Inc.

Bridgewater, NJ

08807

Change the location of the Design Control Center for Sculptra and Sculptra Aethetic from Sanofi Aventis U.S. LLC, Bridgewater, New Jersey to Anagni Italy.
P030052/S007

6/1/11

UroVysion Bladder Cancer Kit Assay Abbott Molecular, Inc.

Des Plaines, IL

60018

Implementation of process change to the manufacture of the FISH DNA bulk probe solution, including a new fISH DNA extraction process, a new sonication equipment, a new amination/labeling procedure, and a supplemental DNA purification processing step to reduce RNA carry-over.
P040002/S032

6/30/11

Powerlink Stent with IntuiTrak Delivery System Endologix, Inc.

Irvine, CA

92618

Alternate supplier of suture material.
P040014/S017

6/6/11

Therapy, Therapy Bi-Directional and Therapy 4 mm Thermistor Cardiac Ablation Catheters St. Jude Medical

Irvine, CA

92614

Implement an additional manufacturing rework step.
P040016/S072

6/30/11

VeriFLEX™ Bare-Metal Coronary Stent System Boston Scientific Corporation

Maple Grove, MN

55311

Implementation of the use of a closed-loop control (feedback), in the extrusion of the tie layer of the tri-layer component.
P040042/S022

6/6/11

Therapy Dual 8, Therapy 8mm Thermistor and Safire TX Ablation Catheters St. Jude Medical

Irvine, CA

92614

Implement an additional manufacturing rework step.
P040045/S019

6/10/11

VISTAKON® (etafilcon A) and (senofilcon) Brand Contact Lenses Vision Care, Inc.

Jacksonville, FL

32256

Replacement of a Differential Scanning Calorimeter (DSC) for a previous model that is no longer supported by the same manufacturer.
P040045/S020

6/8/11

VISTAKON® (senofilcon A) Brand Contact Lenses Johnson & Johnson Vision Care, Inc.

Jacksonville, FL

32256

Evaluation of the automation of the repackaging activities conducted by a qualified supplier.
P040045/S021

6/16/11

VISTAKON® (senofilcon A) Brand Contact Lenses Johnson & Johnson Vision Care, Inc.

Jacksonville, FL

32256

Change in the software for processing laboratory data related to the VISTAKON® (etafilcon A) Brand and VISTAKON® (senofilcon A) Brand Contact Lenses.
P040045/S022

6/15/11

VISTAKON (senofilcon A) Brand Contact Lenses Johnson & Johnson Vision Care, Inc.

Jacksonville, FL

32256

Addition of a cure tunnel lane.
P040045/S023

6/22/11

VISTAKON (senofilcon A) Brand Contact Lenses Johnson & Johnson Vision Care, Inc.

Jacksonville, FL

32256

Use an electronic Raw Material Tracking System.
P050042/S013

6/24/11

ARCHITECT ANTI-HCV Abbott Laboratories Abbott Park, IL

60064

Change in the quality control testing used on an incoming raw material and a finished accessory used in the subject ARCHITECT Assays.
P050046/S011

6/17/11

ACUITY Lead Boston Scientific Corporation

St. Paul, MN

55112

Alternate ingredient for the adhesive used in sterile packaging.
P050051/S013

6/24/11

ARCHITECT AUSAB Abbott Laboratories Abbott Park, IL

60064

Change in the quality control testing used on an incoming raw material and a finished accessory used in the subject ARCHITECT Assays.
P060001/S014

6/27/11

Protégé GPS & Protégé RX Carotid Stent System Ev3 Endovascular Inc.

Plymouth, MN

55441

Alternate etching process for sphere components.
P060007/S015

6/24/11

ARCHITECT HBsAg, ARCHITECT HBsAg Confirmatory Abbott Laboratories Abbott Park, IL

60064

Change in the quality control testing used on an incoming raw material and a finished accessory used in the subject ARCHITECT Assays.
P060008/S071

6/30/11

TAXUS® Liberte® Paclitaxel-Eluting Coronary Stent Systems Boston Scientific Corporation

Maple Grove, MN

55311

Implementation of the use of a closed-loop control (feedback), in the extrusion of the tie layer of the tri-layer component.
P060010/S009

6/14/11

The Spanner Temporary Prostatic Stent AbbeyMoor Medical, Inc.

Parkers Prairie, MN

56351

Minor formulation change in a raw material.
P060022/S011

6/8/11

Akreos Posterior Chamber Intraocular Lens Bausch & Lomb Inc.

Aliso Viejo, CA

92656

Addition of an alternate facility as a source or the Akreos lens button and an alternate supplier of methyl methacrylate.
P060035/S009

6/24/11

ARCHITECT CORE-M Abbott Laboratories Abbott Park, IL

60064

Change in the quality control testing used on an incoming raw material and a finished accessory used in the subject ARCHITECT Assays.
P080006/S026

6/2/11

Attain Ability Family of Leads Medtronic, Inc.

Mounds View, MN

55112

Addition of an additional testing laboratory for sterilization.
P080006/S027

6/8/11

Attain Ability Medtronic, Inc.

Mounds View, MN

55112

Update to the sterile packaging operation process.
P080006/S028

6/10/11

Attain Ability Plus, Attain Ability Straight Medtronic, Inc. Mounds View, MN

55112

Change the cleaning area of the devices.
P080014/S008

6/23/11

Cervista® Papilloma Virus (HPV) High Risk (HR) Hologic LP

Marlborough, MA

01752

Addition of a new supplier of Bovine Serum Albumin (BSA).
P080015/S004

6/23/11

Cervista® Human Papilloma Virus (HPV) 16/18 Hologic LP

Marlborough, MA

01752

Addition of a new supplier of Bovine Serum Albumin (BSA).
P080023/S009

6/24/11

ARCHITECT CORE Abbott Laboratories Abbott Park, IL

60064

Change in the quality control testing used on an incoming raw material and a finished accessory used in the subject ARCHITECT Assays.
P080025/S005

6/16/11

Interstim Family of Implantable Neurostimulators,

Leads, Extension, Test Stimulation Lead, Test Stimulation Kit, Accessories and Accessory Kits for use with Interstim therapy and

Control Magnet

Medtronic, Inc.

Minneapolis, MN

55432

Implement or change software used for manufacturing of several devices.
P080025/S006

6/17/11

InterStim INS and 3058 InterStim II INS Medtronic Neuromodulation

Minneapolis, MN

55432

Addition of an ethylene oxide sterilizer system.
P080025/S007

6/22/11

InterStim Family Medtronic Neuromodulation

Minneapolis, MN

55432

Addition of an alternate qualified supplier for components used in the feedthrough assembly.
P090013/S023

6/8/11

Revo MRI IPG Medtronic, Inc.

Mounds View, MN

55112

Changes to the NeliPak Sealer manufacturing process; including addition of new equipment, a change to the process recipe specification, and the implementation of a monitoring test.
P090013/S024

6/9/11

Revo MRI IPG Medtronic, Inc.

Mounds View, MN

55112

Addition of an ethylene oxide (EtO) sterilizer system.
P090013/S026

6/29/11

CapSureFix MRI Medtronic, Inc.

Mounds View, MN

55112

A lead assembly crimping process improvement.
P100023/S001

6/7/11

Ion (Taxus Element) Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation

Maple Grove, MN

55311

Changes to your cut-to-length process during catheter assembly.
P100023/S004

6/29/11

Ion (Taxus Element) Paclitaxel-Eluting Coronary Stent System Boston Scientific Corporation

Maple Grove, MN

55311

Changes to the proximal Heat Shrinking Removal Inspection Process.

Summary of PMA Originals & Supplements Approved

Originals: 4

Supplements: 78

Summary of PMA Originals Under Review

Total Under Review: 93

Total Active: 35

Total On Hold: 58

Number Greater Than 180 Days: 3

Summary of PMA Supplements Under Review

Total Under Review: 691

Total Active: 501

Total On Hold: 190

Number Greater Than 180 Days: 11

Summary of All PMA Submissions Received

Originals: 3

Supplements: 98

Summary of PMA Supplement PMA Approval/Denial Decision Times

Number of Approvals: 78

Number of Denials: 0

Average Days Fr Receipt to Decision (Total Time): 116.2

FDA Time: 93.3 Days MFR Time: 22.9 Days

SOURCE

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